PROMETRA II Programmable Infusion Pump, Implantable… recallZ-2740-2017 · Flowonix Medical, Inc. · initiated May 22, 2017
Class II Terminated All recalls posted in June 2017
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Flowonix Medical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Flowonix Medical received a report of a patient implanted with the Prometra II Programmable Pump who may have received a fatal drug overdose during an MRI procedure. The Prometra II pump has an FDA-approved design feature intended to permit safe exposure to an MRI without removing drug from the reservoir.
FDA root cause category: Under Investigation by firm
What the company is doing
Flowonix sent an URGENT MEDICAL DEVICE CORRECTION Letter and Response Forms dated May 22, 2017, with updated instructions were sent via UPS 2nd Day Air on May 25, 2017 to healthcare professionals: physicians and MRI facilities and technicians. The documents will also be available at www.flowonix.com. A Correction Letter will also be sent to patients to inform them of the labeling changes. For further questions, please call (973) 426-9229.
Recall details
- Recall number
- Z-2740-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- May 22, 2017
- Posted by the FDA
- Jun 19, 2017
- Recalling firm
- Flowonix Medical, Inc.
- Quantity
- US: 2204 units
- Product code
- LKK
- FDA submissions
- P080012
- Distribution
- Nationwide Distribution
Product description
PROMETRA II Programmable Infusion Pump, Implantable Infusion Pump, Catalog Number/REF 13827, Part Number PL-31790-02. Manufactured by: Flowonix Medical Inc., --- The correction involves the labeling of the device plus the following Prometra II pump labeling is also being revised: Intrathecal Catheter IFU, REF 11823, PL-22790-02; Catheter Revision Kit IFU, REF 11 830, PL-21798-02; Refill Kit IFU, REF 11825, PL-21794-00; Prometra II Patient Implant Card (Permanent) PL-32300-01; Prometra II Patient Implant Card (Temporary): PL-32375-01; Prometra II Patient Guide: PL-31912-01. The Prometra Programmable Infusion Pump System is indicated for intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) or preservative-free sterile 0.9% saline solution (sodium chloride injection, USP).
Code information (models, lots, serial numbers)
All
Other devices under the same FDA submission
8 devices cleared under P080012 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Prometra II Pump 13827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable40 deaths859 reports
- Prometra Intrathecal Catheter 11823Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable1 death322 reports
- Prometra Programmable Pump 11827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable9 deaths83 reports
- Prometra Patient Therapy Controller 12860Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable58 reports
- Prometra Catheter Revision Kit 11830Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable42 reports
- Prometra Programmable Pump 16827Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable32 reports
- Prometra Programmer 12828Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable10 reports
- Prometra Refill Kit 11825Flowonix Medical, Inc. · Pump, Infusion, Implanted, Programmable1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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